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Draeger Medical Systems, Inc. Recall 90423

Description: Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system

Draeger Medical Systems, Inc. Recall 90423 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1365-2022
Event ID90423
Event DescriptionDraeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
Product TypeDevices
DistributionNo US distribution. Foreign distribution to BY, CL, DE, ES, GB, HU, IN, IT, KW, MX, SA, SV, TW.
Quantity38 OUS (no US distribution)
Recall ReasonThe firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.
Device Classification20220720
Device Code InfoModel, country, and serial number: MS20508: El Salvador DSPN-0003 Mexico DSPM-0003, DSPH-0002 Chile DSPL-0003 Saudi Arabia DSPJ-0003, DSPL-0004, DSPL-0005, DSPL-0006, DSPL-0007, DSPM-0001, DSPM-0002, DSPL-0008, DSPK-0002, DSPH-0003, DSPJ-0004, DSRA-0001 Kuwait DSPJ-0002, DSPK-0001 India DSPN-0001, DSPN-0002, DSRA-0002 Taiwan DSPL-0001, SPL-0002, DSPJ-0001 MS20509: Germany DSPH-0003 Qatar DSPL-0007, DSRB-0001 Spain DSPK-0002, DSPJ-0006, DSPJ-0003, DSPH-0001, DSPJ-0004, DSPK-0001, DSPL-0008 Hungary DSPF-0003 Belarus DSPJ-0005 United Kingdom DSPF-0002 Italy DSPJ-0002
Center Classification Date20220711
Recall Initiation Date20220520
Recalling FirmDraeger Medical Systems, Inc.
Initial Notification Letter
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